legal and regulatory challenges to data sharing for clinical genetics and genomics services in the...
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Legal and regulatory challenges to data sharing for clinical genetics and genomics services in the UK
6th Biennial Meeting of the Human Variome Consortium1 June 2016Alison Hall, Head of Humanities, PHG Foundation
Challenge: What is acceptable practice in a complex legal & regulatory landscape?
Identification Very rare genomic variants can be identifiable information depending on context
Complexity of lawsLaws, regulations, contractual and professional obligations
InterpretationInconsistencies between Caldicott Guardians who have responsibility for local NHS Trust practice
Data Protection‘sensitive personal data’‘public interest’‘necessary and proportionate’
ConfidentialityCommon law and derogations • Control of Patient
Information Regulations• s251
Data sharing to support UK clinical genetics & genomics services
Multi-disciplinary workshop
23rd June 201560 delegates
Perceived impediments to data sharing
* From representatives across 15 different NHS clinical genetics laboratories
Data sharing – what are the challenges?
How to share data responsibly and
legally?
Where to deposit/ share data?
How to facilitate data curation and
deposition?
Which data types to share for
clinical service delivery?
Focus group discussions: data sharing by data type
Core recommendations• Sharing genetic / genomic variants is necessary • Current arrangements are unsatisfactory • Data sharing processes need to be streamlined and simplified
• 3 elements are needed to improve, optimise and transform existing practice: Strong leadership by the multiple responsible health
organisations to demonstrate the benefits and risks associated with data sharing and not sharing
National agreement to optimise sharing within the NHS and develop a consensus on the legitimacy of data sharing
Operational agreement on the use of a designated database/infrastructure
Recommendations (2)Data sharing within the NHS
-is necessary for routine NHS care and service delivery-
Rec-2: Where to share?Engagement with stakeholders who are already developing systems and applications
Rec-3: What to share?Minimum: all disease causing / potentially disease causing variants should be shared
Rec-4: How to share? Safeguarding Data deposition, sharing and curation are essential and must be safeguarded
Rec-5: How to share? Professional guidelinesBest practice guidelines for data sharing for clinical genetics & genomics practice should be developed
Rec-6: Future proofingMechanisms ought to be established for sharing & managing whole genome & exome data
Recommendations (3)
Rec-7: Sharing beyond the NHSSystems and legal processes need to be put in place to allow NHS content to be shared more widely outside the NHS
Data sharing beyond the NHS
Recommendations (4)
Wider considerations – achieving consistent and supported data sharing
Rec-9: Building trustTo facilitate public engagement and public trust, there needs to be a concerted effort by NHS providers and other relevant stakeholders to inform patients about how their data are used
Rec-11: Consensus development & proportionalityA collaborative, multi-agency assessment of the risks of privacy breaches occurring and the impact they may have on patients, as well as the risks and impact on patients of not sharing data, is warranted
Rec-10: Assessing use [and misuse] Relevant regulatory agencies and professional groups should work together to ensure that there are harmonised appropriate approaches to evaluating and assessing health and care data use
Rec-8: Ensuring complianceOnce a robust data sharing model has been established, data sharing should be made more robust by mandating requirements for sharing genetic variants and monitoring compliance
Core recommendations: key stakeholders
NHS (E/S/W) Department of
Health
National Information Board
Genomics England
Clinical Genetics community & professionals
Professional groups: ACGS; BSGM
Council of Caldicott Guardians
Existing data-sharing initiativesInformation
Governance Alliance
Information Commissioners Office
National Data Guardian
NHS Digital (formerly HSCIC)
Generalisability? Key elements• Pre-workshop survey to gather evidence
and prioritise challenges• Multidisciplinary workshop
– Representatives sought from every lab– Joint meeting encouraged attendance– Mix of high-level presentations and small focus
groups to foster engagement
• Proactive advocacy– Statutory bodies: National Information
Board – Project based: Ethical Advisory Committee
100,000 GP– Professional meetings: ESHG, Curating the
Clinical Genome (ClinGen/DECIPHER 2016), Association for Clinical Genetic Science
Other driversNational flagship project
– 100,000 Genomes Project– Expertise and funding to build data sharing
infrastructure– Hybrid project straddling clinical
care and research
National Data Guardian review of data security and consent/objection (UK)
– Extensible and generalisable whole system consent-based approach to sensitive data
– Guidelines for the protection of personal data and wording for a new model of consent /objection
EU General Data Protection Regulation
– Finalised text published 27 April 2016– Processing for scientific research purposes
subject to appropriate safeguards – Derogations at Union or Member State level
Since the workshop • 250% increase in the number of cases shared in the NHS
Consortium DECIPHER project
• And an increase in the centres involved from six to eleven
• Revised ACGS best practice guidelines on data sharing
6,662 cases Before 23rd June 2015
Over 16,300 patient records April 2016
Challenges: safeguarding autonomy and trust
• Respecting concerns: Health and Social Care Information Centre (HSCIC) patient opt-outs predicated upon ‘direct care’ – Type 1: Prevents identifiable information being
shared outside a GP practice for purposes other than direct care
– Type 2: Prevents identifiable information being shared outside of the Health and Social Care Information Centre for purposes beyond the individual’s direct care
• Research on public attitudes to commercial use (IPSOS MORI)– Low public awareness of current data use– Support for more effective within NHS sharing– Genetic data ‘both most private, and most
potentially valuable’ – 54% ‘ask permission’; 17% ‘opposed to sharing
for research’– Hierarchy of WHY, WHO, WHAT and HOW– Changing safeguards did not change outcomes
Data use ob-jections
No objec-tionType 1Type 2
https://www.ipsos-mori.com/Assets/Docs/Publications/sri-wellcome-trust-commercial-access-to-health-data.pdf
Priorities for policy making Demonstrating necessity Evidencing proportionality
e.g. minimising disclosure - maximising utility
Clinical care Sharing across health and social care More use of role-based access
Robust regulatory framework Legislative support where necessary New categories for accessing genomic data [Controlled – Restricted – Open Access]
Greater harmonisation Consistent terminology
GA4GH Data Sharing Lexicon
